510(k) K112435

RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT by Rhythmlink International, LLC — Product Code ETN

K112435 is an FDA 510(k) premarket notification submitted by Rhythmlink International, LLC for the device "RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on September 22, 2011. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Rhythmlink International, LLC has at least 10 other 510(k) clearances on record.